WaveSense Jazz Blood Glucose Monitoring System

K241304 · Agamatrix · NBW · Jun 6, 2024 · Clinical Chemistry

Device Facts

• Record ID: K241304
• Device Name: WaveSense Jazz Blood Glucose Monitoring System
• Applicant: Agamatrix
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 6, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip, palm, or forearm. The system is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Device Story

WaveSense Jazz Blood Glucose Monitoring System; in vitro diagnostic device for quantitative glucose measurement in capillary whole blood. System comprises meter, test strips, and control solution. User applies blood sample to test strip; meter performs electrochemical analysis to determine glucose concentration. Modifications include addition of target range indicator colors to meter housing; software update to display glucose measurement status (below, within, or above user-set target range); LCD display layout adjustment; updated disinfection instructions. Used by patients at home for self-monitoring of diabetes. Output displayed on LCD; informs patient of glucose level relative to target range to assist in diabetes management. Device validated for 5-year single-patient use with Super Sani-Cloth Germicidal Disposable Wipes.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by verification and validation activities, including robustness testing, firmware functional testing, and usability engineering evaluations.

Technological Characteristics

Electrochemical glucose monitoring system. Modifications: added target range indicator colors to housing, updated LCD display, software-based target range notification. Validated for 5-year use with Super Sani-Cloth Germicidal Disposable Wipes (EPA Reg. No. 9480-4).

Indications for Use

Indicated for persons with diabetes for quantitative measurement of glucose in fresh capillary whole blood from finger stick, palm, or forearm. For home (OTC) use as an aid to monitor diabetes control. Not for use with neonates.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• WaveSense Jazz Blood Glucose Monitoring System (K072413)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K241304

B Applicant

AgaMatrix

C Proprietary and Established Names

WaveSense Jazz Blood Glucose Monitoring System

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NBW | Class II | 21 CFR 862.1345 - Glucose Test System | CH - Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: Jazz Blood Glucose Monitoring System, K072413.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for:

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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- Add target range indicator colors to the meter top housing.
- Software change: add target range indicator to indicate to the user whether a measurement is below, within or above the user-set target glucose ranges.
- LCD modification to adjust style and location of information on the display.
- The device labeling is updated accordingly to reflect the modifications and disinfection instructions are added.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

The device system is intended for single patient use only. Disinfection efficacy studies were performed on the exterior meter materials demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant Super Sani-Cloth Germicidal Disposable Wipe (EPA Reg. No.: 9480-4). A robustness study was also performed by the sponsor demonstrating that there was no change in performance or in external materials of the meter after 260 cleaning and disinfection cycles to support 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

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